Michael Healy-Rae (Kerry South, Independent)
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243. To ask the Minister for Health further to Parliamentary Question No.472 of 29 September 2015, the reason the matter was not addressed; and if he will make a statement on the matter. [35336/15]

Michael Healy-Rae (Kerry South, Independent)
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244. To ask the Minister for Health his plans to make it mandatory to report and publicise adverse drug reactions in relation to Roaccutane; and if he will make a statement on the matter. [35337/15]

Michael Healy-Rae (Kerry South, Independent)
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245. To ask the Minister for Health if the original product information, all records and updates, archive, database and otherwise for Roaccutane will be provided, along with the individual reasons for each update and change since its introduction on 19 April 1983 to the present; and if he will make a statement on the matter. [35338/15]

Michael Healy-Rae (Kerry South, Independent)
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246. To ask the Minister for Health if he will provide the physicians' guide, the physicians' checklist, for prescribing Roaccutane; the important information for patients prescribed Roaccutane on contraception; the pharmacists' guide to dispensing Roaccutane for female and male patients; the pregnancy prevention plans for Roaccutane since 1983 to the present; and if he will make a statement on the matter. [35339/15]

Michael Healy-Rae (Kerry South, Independent)
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258. To ask the Minister for Health further to Parliamentary Question No. 790 of 22 September 2015, if he will address a matter (details supplied); and if he will make a statement on the matter. [35391/15]

Michael Healy-Rae (Kerry South, Independent)
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261. To ask the Minister for Health his views on a matter (details supplied) regarding the drug Roaccutane; and if he will make a statement on the matter. [35399/15]

Kathleen Lynch (Cork North Central, Labour)
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I propose to take Questions Nos. 243 to 246, inclusive, 258 and 261 together.

Roaccutane (isotretinoin) is authorised for treating severe forms of acne which have been resistant to other standard therapies. When first authorised for use in Ireland in 1983, Roaccutane was authorised for the management of cystic or conglobate forms of acne vulgaris, or for use in cases of severe acne which have failed to respond to adequate courses of accepted therapy.

Information is not collected in relation to the clinical condition for which a drug is prescribed in individual cases. In relation to Roaccutane the only available information relates to the number of prescriptions dispensed under the GMS and Community Drugs Schemes. This information was provided to the Deputy by the HSE in response to a previous parliamentary question (Ref no. 33338/15).

The information breakdown held by the HPRA that the Deputy refers to is the breakdown of reported adverse reactions notified to the HPRA and I understand that the HPRA has provided this breakdown directly to the Deputy. Of the five cases where Roaccutane was used for an unknown indication, the HPRA made efforts to obtain this information from the person reporting the adverse reaction but such information was not forthcoming.

European and Irish legislation provides for ongoing monitoring of the benefits and risks of medicines through a system known as pharmacovigilance. This monitoring includes review and evaluation of suspected adverse reaction reports at National and EU level. The national regulatory medicines authorities (in Ireland the HPRA) in each EU Member State are responsible for gathering and evaluating national adverse reaction reports and in turn submitting these reports to the European Medicines Agency, which is responsible for the overall co-ordination of pharmacovigilance activities across the EU.

In accordance with European and national legislation, marketing authorisation holders (manufacturers) are legally obliged to notify all suspected serious adverse reactions in Ireland (reported either by a healthcare professional or a patient) to the HPRA within 15 days of first notification of the company. Reporting of suspected adverse reactions by health professionals and patients is undertaken on a voluntary basis across the EU with all health professionals strongly encouraged to report any suspected adverse reaction. International data indicates that Ireland has a high rate of reporting and the HPRA regularly reminds health care professionals about reporting in its Drugs Safety Newsletter.

In previous replies to the Deputy I have provided detailed information on the authorisation process for a medicine and the safety monitoring process once the medicine is placed on the market. Before it can be made available to patients a medicine must meet predefined standards of quality, safety and efficacy and approval is given on the basis of a favourable benefit versus risk balance for a specific indication.

There is in addition extensive pharmacovigilance legislation which monitors the medicine’s safety once it is in use to ensure that risks can be promptly identified and managed so that harm is prevented. Reporting of suspected adverse reactions is only one of a number of ways of identifying new adverse reactions. However individual reports of suspected adverse reactions alone are rarely sufficient to confirm that a certain reaction is caused by the medicine in question. Other factors such as the extent and conditions of use of the medicine, the nature of the reaction, the condition being treated, any new conditions arising and other medicines taken by the patient have all to be taken into account. Further data is usually required, including worldwide spontaneous case reports, clinical trials and epidemiological studies, to confirm the reactions and help determine their significance.

A review of Roacccutane across the EU took place in 2011 when further warnings regarding skin reactions were added to the product information for patients and their doctors. The risk of depression associated with Roaccutane was also reviewed at that time. However it was concluded on the basis of all the available evidence that the existing monitoring requirements provided on the product information is sufficient.

In conclusion therefore no medicine is without risk but the extensive authorisation and monitoring process in place across the EU ensures that risks are identified and managed.

The Deputy will have previously received from the HPRA a copy of the current product information. I am arranging to forward the Deputy a copy of the original product authorisation from 1983. Following authorisation any change (e.g. new indications, updated safety information, product changes) require approval on foot of a formal application to vary the authorisation and the submission of relevant supporting data. In practice product information changes frequently. Information relating to all these the changes is not readily available in the HPRA and will entail detailed searches through archived material.

However the HPRA is happy to meet the Deputy to discuss his information requirements further and will be communicating directly with the Deputy in coming days to arrange a meeting.

Since it was first authorised for use in Ireland, Roaccutane has been contraindicated in women who are pregnant or breastfeeding. An EU wide Pregnancy Prevention Plan (PPP) was introduced in October 2003 to further reduce the potential risk of pregnancy in women. The Plan consists of key educational information on the risks of treatment and specific criteria for managing therapy in women of child-bearing potential. I am arranging to send the Deputy copies of material distributed by the marketing authorisation holder for use by prescribing doctors, pharmacists, other relevant healthcare professionals and patients, including a checklist for prescribing to female patients.

In addition the Medicinal Products (Prescription and Control of Supply) Regulations 2003 were amended in 2005 to introduce restrictions on certain medicines containing Isotretinoin. Regulation 7(9) of the Regulations provides that the prescription of a medicine containing Isotretinoin which is intended for the treatment of a woman of childbearing potential, shall not be dispensed later than seven days after the date on the prescription and the treatment shall not exceed a period of thirty days.

While the legislation does not restrict the type of medical practitioner that can prescribe Isotretinoin, the product’s product information (SmPC) requires that the product should only be prescribed by or under the supervision of physicians with expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements.